Breast CancerFluoropolyMeshNCT07185334

Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer

A study testing Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants. and Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants. in people with Breast Cancer and Breast Reconstruction, run by Saint Petersburg State University, Russia at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Breast Reconstruction, Coated Materials
What is being tested?: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants. and Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteRussia
Study dates: 15 May 2025to 15 May 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women with a verified breast cancer diagnosis over 18 years of age;
ECOG 0-1;
Stage: clinical T1, T2 or T3, N0-3, M0;
The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm
Signed informed voluntary consent.

Who cannot join

Women under 18 years of age;
ECOG 2-4;
Stage: clinical T4, M1;
The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm;
Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;

Trial locations and contacts

1 site in 1 country.

Russia1 site

Saint Petersburg State University
Saint Petersburg

Other trials in Russia

About this study

Read the detailed description

The study includes female patients aged 18 and above with a verified breast cancer diagnosis, ECOG performance status 0-1, and clinical stage T1-T3, N0-3, M0, who provide informed consent. Exclusion criteria involve intolerance or allergic reactions to mesh endoprostheses or implants and a subcutaneous adipose tissue thickness of less than 5 mm (measured via Pinch Test). Participants will be non-randomly allocated into two groups: the main group, receiving a polyester mesh endoprosthesis with fluoropolymer coating alongside textured implants, and the control group, receiving textured implants alone. Surgical procedures will involve subcutaneous mastectomy with implant placement based on preoperative measurements of breast dimensions, with or without nipple-areolar complex preservation. Postoperative follow-ups at 1, 3-6, and 9-12 months will assess complications such as protrusions, seromas, implant contouring (rippling), capsular contracture, and dystopia via physical examination and ultrasound. The hypothesis posits that the use of mesh endoprostheses will lower protrusion rates compared to standard implant placement, offering a potential advancement in reducing postoperative risks in breast reconstruction for breast cancer patients.

Conditions: Breast Cancer, Breast Reconstruction, Coated Materials, Reconstruction Breast Surgery, MASH With Fibrosis
Being tested: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants., Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
Keywords: Fluoropolymer coated mesh, Implant-based reconstruction in breast cancer patients
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.Procedure or surgery
For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants.
Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.Procedure or surgery
This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

Study groups in NCT07185334
Study group	Role	What they receive
Main group	Experimental	The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants. Receives: Procedure: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.
Control group	Other	The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating Receives: Procedure: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of protrusions throughout the year
Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised.
Measured: 1 year

Secondary outcomes (1)

1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia
1. Seroma is a pathological accumulation of serous fluid in the tissues after surgery or trauma. Most often, this condition develops after operations that affect large areas of the skin and subcutaneous fat.
2. Rippling - represents contouring of the implant through the surface of the mammary glands, expressed by folds in the area of implantplacement.Sometimes it is called "skin ripples" or"washboard effect".
3. Capsular contracture is the formation of connective tissue around the implant, resulting in compression and deformation of the prosthesis.
4. Dystopia is a displacement of the implant relative to its original correct anatomical position, which leads to breast deformity, asymmetry, or functional discomfort
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202515 May 2027

First posted22 Sep 2025
Study start15 May 2025
Primary completion15 May 2026 (estimated)
Study completion15 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Main group- The main group will consist of patients undergoing surgical treatment for subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating, with simultaneous prepectoral placement of textured implants. Control group-The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07185334
Sponsor's protocol ID: 50
Acronym: FluoropolyMesh
Status last verified: Sep 2025
First submitted: 2 Sep 2025
Last updated: 22 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT07185334
Acronym / sponsor ID: FluoropolyMesh / 50
Conditions: Breast Cancer, Breast Reconstruction, Coated Materials, Reconstruction Breast Surgery, MASH With Fibrosis
Keywords: Fluoropolymer coated mesh, Implant-based reconstruction in breast cancer patients
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Saint Petersburg State University, RussiaUniversity, hospital or other
Study start: 15 May 2025 (actual)
Primary completion: 15 May 2026 (estimated)
Study completion: 15 May 2027 (estimated)
First posted: 22 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Main group- The main group will consist of patients undergoing surgical treatment for subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating, with simultaneous prepectoral placement of textured implants. Control group-The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants.

Arm	Type	Receives
Main group	Experimental	Procedure: Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants.
Control group	Other	Procedure: Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Women with a verified breast cancer diagnosis over 18 years of age;
ECOG 0-1;
Stage: clinical T1, T2 or T3, N0-3, M0;
The thickness of subcutaneous adipose tissue (Pinch Test) is more than 5 mm
Signed informed voluntary consent.

Key exclusion criteria (5 listed)

Women under 18 years of age;
ECOG 2-4;
Stage: clinical T4, M1;
The thickness of subcutaneous adipose tissue (Pinch Test) is less than 5 mm;
Intolerance and / or allergic reaction to the mesh endoprosthesis, implant and/or its component;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants.For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants.	Procedure or surgery	Main group
Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.	Procedure or surgery	Control group

Primary outcome

Frequency of protrusions throughout the year
Time frame: 1 year
Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised.

1 secondary outcome

1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia
Time frame: 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

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Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of protrusions throughout the year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.